Legend Biotech Added to the NASDAQ Biotechnology Index

On December 14, 2020 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI) (Press release, Legend Biotech, DEC 14, 2020, View Source [SID1234572827]). The annual re-ranking of the NASDAQ Biotechnology Index will become effective prior to market open on Monday, December 21, 2020. For this year’s re-ranking of the index, 100 biotech stocks were added and 16 were removed.

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The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB), and which also meet other eligibility criteria. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology. For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit www.nasdaq.com.

Rocket Pharmaceuticals Announces Closing of Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

On December 14, 2020 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported the closing of its previously announced upsized underwritten public offering of 5,339,286 shares of its common stock, including the exercise in full by the underwriters of their option to purchase an additional 696,428 shares, at the public offering price of $56.00 per share (Press release, Rocket Pharmaceuticals, DEC 14, 2020, View Source [SID1234572826]). The gross proceeds to Rocket from the offering are expected to be approximately $299 million, before deducting the underwriting discounts and commissions and other offering expenses.

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Rocket intends to use the net proceeds from this offering to further fund the development of its pipeline of gene therapies for rare diseases, including filing for marketing authorization for RP-L201 in the United States and Europe, accelerating the buildout of in-house manufacturing capabilities, and for general corporate purposes.

J.P. Morgan, BofA Securities, SVB Leerink and Piper Sandler acted as the joint bookrunning managers for the public offering.

The public offering was made by Rocket pursuant to an effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC. A final prospectus supplement relating to and describing the terms of this offering was filed with the SEC on December 11, 2020. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected], from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected], or from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected]. You may also obtain these documents free of charge by visiting the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Kezar Life Sciences Added to the Nasdaq Biotechnology Index

On December 14, 2020 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that it has been added to the NASDAQ Biotech Index (Nasdaq: NBI), effective prior to market open on Monday, December 21, 2020 (Press release, Kezar Life Sciences, DEC 14, 2020, View Source [SID1234572825]).

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The NASDAQ Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market (Nasdaq) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology. Companies in the NASDAQ Biotechnology Index must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. Nasdaq selects constituents once annually in December.

PharmaCyte Biotech Begins Physical Testing of CypCaps in Response to FDA Recommendations for its Clinical Trial Product

On December 14, 2020 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has commenced additional physical parameter testing of its CypCaps product for pancreatic cancer, in line with the recommendations provided by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, DEC 14, 2020, View Source [SID1234572824]).

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The FDA has asked that two additional methods be developed to determine the strength of PharmaCyte’s encapsulated cells (CypCaps) to be used in the company’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC). One method involves pressing down on the capsule and measuring either the pressure required for it to burst, or for it to deform. Since the CypCaps are very small, special machinery that can measure such tiny changes has to be used to demonstrate this. The necessary machinery is now being incorporated as a quality control test for the CypCaps.

The second method involves letting water flow into the CypCaps, effectively "blowing them up." The point at which the capsules explode will be used as a quality control parameter.

Previous work has shown the pressures and water conditions used in these tests to be well outside of the normal conditions encountered by the capsules inside the human body, so these tests are designed to simulate hypothetical conditions.

Earlier studies have shown that the capsules do not burst even when placed under very high pressure. Further, even in the very unlikely event that the capsule could break open, the cells inside will be recognized as foreign bodies by the immune system. Also, the encapsulated cells are primed for their suicide since they express the cytochrome P450 gene and thus would be killed by the low dose ifosfamide given as part of the treatment for LAPC.

Thus, these FDA mandated studies can be seen as additional release tests to ensure the reproducibility of the CypCaps.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are pleased to announce the development of these two new quality parameters and their incorporation into the quality testing as one of the additional studies requested by the FDA. In the meantime, PharmaCyte continues to work with its partners to address the other issues raised by the FDA that led to the clinical hold."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

CEL-SCI Corporation to Present at the 13th Annual LD Micro Main Event Conference

On December 14, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it will be presenting at the 13th Annual LD Micro Main Event Conference on Tuesday, December 15, 2020 at 10:00 a.m. ET. Geert Kersten, Chief Executive Officer of CEL-SCI, will be presenting to a live virtual audience (Press release, Cel-Sci, DEC 14, 2020, View Source [SID1234572823]).

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CEL-SCI’s presentation will be broadcast live at View Source or on the Investor Relations section of CEL-SCI’s website at cel-sci.com/new-investor-information/.

LD Micro’s Main Event will feature a new format, with companies presenting for 10 minutes, followed by 10 minutes of Q&A by a panel of investors and analysts.